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New Research Compares Drug Regulators Around the Globe By Zachary Brennan - Published 11 August 2017

Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of various regulators’ budgets, staff, new drug approvals and timelines for approvals.

Categories: News, Asia, Canada, Europe, US, Anvisa, CFDA, EMA, FDA, MHRA, PMDA, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: comparison of drug regulators, new drug approval times, drug regulator reviewers

FDA Commissioner Scott Gottlieb’s Keynote Among Highly Anticipated Sessions at RAPS Regulatory Convergence By Zachary Brousseau - Published 10 August 2017

RAPS will host its annual Regulatory Convergence conference at the Gaylord National Resort and Convention Center at National Harbor on the DC waterfront 9–12 September. This year’s event features more than 75 educational sessions and over 200 speakers, including an opening keynote from FDA Commissioner Scott Gottlieb.

Categories: HTML, Articles, Under RAPS, Anvisa, EMA, FDA, MHRA, PMDA, WHO, RAPS

BIO Highlights IP Challenges Around the Globe By Zachary Brennan - Published 07 August 2017

As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products.

Categories: News, Africa, Asia, Middle East, Anvisa, CFDA, Biologics and biotechnology, Drugs, Government affairs

Tags: intellectual property BIO, biopharmaceutical patents, ANVISA, IP protections

IMDRF Offers a Preview of Next Week’s Vancouver Meeting By Zachary Brennan - Published 06 March 2017

Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.

Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IMDRF, MDR, IVDR, MDUFA, Cures

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs

ICH Looks to Revamp GCP Guidelines, Adds New Members By Michael Mezher - Published 17 November 2016

Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week.

Categories: News, Anvisa, ICH, MFDS, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy

Tags: ICH, International Council for Harmonisation, Good clinical practice, GCP, Real world evidence

ICH Adds 14 New Observers, Adopts New Guidelines at Lisbon Meeting By Zachary Brennan - Published 01 July 2016

The recently renamed International Council for Harmonisation (ICH) is adding new pharmaceutical and medical device regulators, industry groups and the US Pharmacopeia into its ranks as observers.

Categories: News, Asia, Canada, Europe, Oceania, US, Anvisa, CDSCO, CFDA, EMA, FDA, Health Canada, ICH, MHRA, PMDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: ICH observers, pharmaceutical regulatory harmonization

Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections By Zachary Brennan - Published 29 June 2016

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are making significant progress toward mutually recognizing each other’s good manufacturing practice (GMP) pharmaceutical inspections.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, US, Anvisa, EMA, FDA, ICH, MHRA, TGA, WHO, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: ICMRA, GMP inspections, mutual recognition, FDA and EMA relationship

Regulatory Recon: FDA Approves New Renal Cell Carcinoma Drug; Reduced ANVISA Fees for Some Due to Lawsuit (26 April 2016) By Zachary Brennan - Published 26 April 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, Middle East, US, Anvisa, CDSCO, EC, EMA, FDA, Health Canada, IMDRF, MHRA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Labeling, Manufacturing

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

IMDRF Offers Progress Updates at March Meeting By Zachary Brennan - Published 01 April 2016

The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, Anvisa, EC, EMA, FDA, Health Canada, IMDRF, MHLW, PMDA, WHO, Clinical, Compliance, Due Diligence, Government affairs, Manufacturing, Medical Devices, Quality

Tags: IMDRF, medical device regulations, MDSAP, international medical device regulations, medical software

Genetically Engineered Mosquitoes to Aid Zika Response? FDA Plans to Release More Info By Michael Mezher - Published 02 March 2016

The US Food and Drug Administration's (FDA) acting chief scientist told members of the House Energy and Commerce Committee on Wednesday that FDA is investigating all avenues to combat Zika, including a proposal to release genetically engineered mosquitoes in Florida.

Categories: News, Latin America and Caribbean, US, Anvisa, FDA, Biologics and biotechnology, In vitro diagnostics

Tags: Zika, Zika virus, MAC-ELISA, CDC, NIAID, Oxitec

MHRA Calls for Continued Quarantine of Silimed Implants By Zachary Brennan - Published 08 January 2016

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday reiterated its call to quarantine implants manufactured by Brazil’s Silimed, saying it’s still trying to determine if there are potential health risks associated with particles found on the surface of the devices.

Categories: News, Asia, Europe, Oceania, US, Anvisa, EC, FDA, MHRA, TGA, Manufacturing, Medical Devices, Postmarket surveillance

Tags: MHRA, Silimed, Sientra, breast implants

Regulatory Recon: Shkreli Arrested on Securities Fraud Charges (17 December 2015) Published 17 December 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, Anvisa, CDSCO, DOJ, EMA, FDA, MHRA, TGA, Biologics and biotechnology, Business Skills, Combination products, Crisis management, Distribution, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices, Quality

Tags: Shkreli, generic drug pricing, Sarepta, biosimilars

MDSAP to Continue Past Pilot Phase in 2016 By Zachary Brennan - Published 28 October 2015

Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday.

Categories: News, Asia, Canada, Europe, Oceania, US, Anvisa, EC, FDA, GHTF, Health Canada, IMDRF, MHLW, PMDA, TGA, WHO, Audit, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence

Tags: MDSAP, medical device single audit program, FDA pilot program, US FDA, TGA, PMDA

FDA Calls for 'Cautionary Approach' on Brazilian Manufacturer's Suspended Implants By Zachary Brennan - Published 14 October 2015

The US Food and Drug Administration (FDA) told RAPS' Regulatory Focus that it concurs with breast implant provider Sientra's caution in voluntarily placing a temporary hold on the US sales of all devices from Brazilian implant manufacturer Silimed.

Categories: News, Europe, Oceania, US, Anvisa, FDA, MHRA, TGA, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: FDA, MHRA, ANVISA, Silimed, breast implants, particle contamination

Acting FDA Commissioner Stephen Ostroff, Author Daniel Pink to Headline RAPS' Regulatory Convergence Conference in Baltimore By Zachary Brousseau - Published 07 October 2015

RAPS’ annual Regulatory Convergence is now less than three weeks away. The event, taking place this year 24–28 October in Baltimore, is the largest annual gathering of the global healthcare regulatory community, including healthcare product regulators, scientists, innovators, and regulatory professionals from life sciences companies of all sizes. This year’s conference will feature keynote remarks from Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff; and best-selling author and TV host Daniel Pink.

Categories: HTML, Articles, Under RAPS, RAPS Events, Anvisa, EMA, FDA, Health Canada, MHLW, MHRA, PMDA, WHO, DC/Baltimore Area Chapter, RAPS

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, Baltimore, Ostroff, Pink

Fallout Continues from MHRA Suspension of Brazilian Manufacturer's Implants By Zachary Brennan - Published 25 September 2015

Two days since the UK's Medicines and Healthcare products Regulatory Agency (MHRA) halted all sales of Silimed's silicone implants, and at least two other regulators have followed suit, while Silimed insists its devices are safe and has criticized MHRA's criteria for particle levels.

Categories: News, Europe, Oceania, US, Anvisa, MHRA, TGA, Compliance, Crisis management, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MHRA, Silimed, plastic surgery, breast implants, silicone implants

A Global Regulatory Gathering in FDA's Backyard By Zachary Brousseau - Published 03 September 2015

RAPS’ 2015 Regulatory Convergence will bring together regulatory professionals, experts and agency representatives from all over the world, including FDA’s acting commissioner and other FDA officials, as well as representatives from at least 22 global agencies and organizations.

Categories: HTML, Articles, Under RAPS, RAPS Events, Anvisa, CFDA, EMA, FDA, Health Canada, MFDS, MHLW, MHRA, PMDA, WHO, RAPS

Tags: Regulatory Convergence, conference, annual conference, regulatory agencies

ANVISA Extends Deadline for Technical Requirement Responses in Brazil By Stewart Eisenhart, Emergo - Published 10 June 2015

Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions.

Categories: News, Latin America and Caribbean, Anvisa, Medical Devices, Submission and registration

Tags: Emergo, Emergo Group, Brazil

Brazil Harmonizes Device Clinical Testing Requirements with International Standards By Stewart Eisenhart, Emergo - Published 06 March 2015

ANVISA, Brazil’s medical device market regulatory agency, has published new requirements for conducting clinical testing of devices in the country.

Categories: News, Latin America and Caribbean, Anvisa, Clinical, Medical Devices

Tags: Emergo, Emergo Group

Brazil's ANVISA Granted More Leverage to Prioritize Medical Device-Related Health Risks By Stewart Eisenhart, Emergo - Published 26 January 2015

A new Brazilian law allows ANVISA, the country’s medical device market regulator, greater latitude to manage public health risks and surveillance measures in a way that may also boost efficiencies for Brazilian market registrants.

Categories: News, Latin America and Caribbean, Anvisa, Medical Devices, Quality, Submission and registration

Tags: Emergo, Brazil

EMA to Share Information About Generic Drugs With Other Regulators By Michael Mezher - Published 20 January 2015

The European Medicines Agency (EMA) has announced it is ready to begin sharing its assessments of generic drugs as part of an ongoing pilot with participating regulatory authorities. The goal of the pilot program, known as the International Generic Drug Regulators Pilot (IGDRP), is to bolster collaboration with regulators around the world and address the challenge of assessing generic drug applications.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Oceania, Anvisa, CFDA, EMA, Health Canada, MFDS, PMDA, TGA, WHO, Generic drugs, Submission and registration

Tags: IGDRP, Generic Drugs, Decentralized Procedure, International Generic Drug Regulators Pilot

ANVISA to Allow Medical Device Firms to Evaluate Their Inspections By Stewart Eisenhart, Emergo Group - Published 18 November 2014

Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes.

Categories: News, Latin America and Caribbean, Anvisa, Medical Devices, Quality

Tags: Emergo Group, Brazil, Quality Management, Brazilian GMP

ANVISA Allowing Automatic Deadline Extensions for Medical Device Registrants By Stewart Eisenhart, Emergo Group - Published 05 November 2014

Brazilian medical device market regulator ANVISA has begun allowing automatic extensions for deadlines for market registrants to comply with new requirements issued by the regulator.

Categories: News, Latin America and Caribbean, Anvisa, Medical Devices, Submission and registration

Tags: Registration, Brazil

Anvisa Updates BA, BE Test Best Practices Certification By Louise Zornoza, RegLink News - Published 10 October 2014

Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies. 

Categories: News, Latin America and Caribbean, Anvisa, Compliance, Generic drugs

Tags: BA, BE, Bioavailability, Bioequivalence, Certification of Good Practice